Drug Type Monoclonal antibody |
Synonyms Daratumumab (Genetical Recombination), 达拉图单抗, 达雷木单抗 + [7] |
Target |
Action inhibitors |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 Nov 2015), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Conditional marketing approval (China), Priority Review (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10777 | Daratumumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Smoldering Multiple Myeloma | European Union | 24 Jul 2025 | |
| Smoldering Multiple Myeloma | Iceland | 24 Jul 2025 | |
| Smoldering Multiple Myeloma | Liechtenstein | 24 Jul 2025 | |
| Smoldering Multiple Myeloma | Norway | 24 Jul 2025 | |
| Immunoglobulin Light-Chain Amyloidosis | European Union | 20 May 2016 | |
| Immunoglobulin Light-Chain Amyloidosis | Iceland | 20 May 2016 | |
| Immunoglobulin Light-Chain Amyloidosis | Liechtenstein | 20 May 2016 | |
| Immunoglobulin Light-Chain Amyloidosis | Norway | 20 May 2016 | |
| Refractory Multiple Myeloma | European Union | 20 May 2016 | |
| Refractory Multiple Myeloma | Iceland | 20 May 2016 | |
| Refractory Multiple Myeloma | Liechtenstein | 20 May 2016 | |
| Refractory Multiple Myeloma | Norway | 20 May 2016 | |
| Relapse multiple myeloma | European Union | 20 May 2016 | |
| Relapse multiple myeloma | Iceland | 20 May 2016 | |
| Relapse multiple myeloma | Liechtenstein | 20 May 2016 | |
| Relapse multiple myeloma | Norway | 20 May 2016 | |
| Multiple Myeloma | United States | 16 Nov 2015 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Residual Neoplasm | Phase 3 | United States | 26 Apr 2019 | |
| Residual Neoplasm | Phase 3 | Canada | 26 Apr 2019 | |
| Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Belgium | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Belgium | 10 Oct 2017 |
Phase 3 | 390 | zdrzgifbmk(kvlrwshttt) = ycpmtpqhbu jdewndrefq (nowaywfzqh, vltszjxpoa - gtdqboqocf) View more | - | 23 Dec 2025 | |||
Not Applicable | 232 | (vWF:Ag <210 U/dL) | aqwevljtzm(vhmnuppxfp) = zlnwlpzljm shfjctbiew (jadryiwblv ) View more | Positive | 06 Dec 2025 | ||
(vWF:Ag ≥210 U/dL) | aqwevljtzm(vhmnuppxfp) = ggbqxlmnok shfjctbiew (jadryiwblv ) View more | ||||||
Phase 3 | Multiple Myeloma Maintenance | 89 | ngndothwvt(hywbcxxcxv) = There was a significant increase in GHS per cycle (mean increase 0.18; 95%CI 0.11, 0.25) on maintenance. There was no difference in the primary endpoint of GHS between two arms (p=0.9). jynzanypup (pdmrjbovzl ) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 28 | Subcutaneous Daratumumab | vqrdchozru(fxanxzuqcm) = during and/or immediately after home administration, only one pt (3.6%) had adverse events (grade 2 allergic reaction according WHO), leading to dara permanent discontinuation. Main adverse events during the home management were infections (pneumonia in 4 pts, FUO in 1) mynkurrgwz (gysrxuxymr ) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 20 | prpnkckiwd(iutlgzwcyz) = 2 clinical relapses occurred: 1 in a daratumumab responder and 1 in a non-responder mrhstcihqu (unimoktosb ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | Multiple Myeloma First line | 446 | Daratumumab based therapy | htfdrdgkyd(miojaybrpc) = dfmojnjpiu sadpbuqvnx (xeppoehbha ) | Positive | 06 Dec 2025 | |
Immunomodulatory imide and proteasome inhibitor-based therapy | htfdrdgkyd(miojaybrpc) = cfdzxpxkqu sadpbuqvnx (xeppoehbha ) | ||||||
Phase 2 | 24 | (MCD) | ymtrwrzgbm(kzffxrihdv) = mfynjevcvl renlgrdmrk (pgmujqnqzj, 1.1 - 45.7) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 95 | Daratumumab+CyBorD | bkbpgfsgmv(zkphqdhbrg) = eoefbvuwft swtsjrnlqz (cikxjiimtv ) View more | Positive | 06 Dec 2025 | ||
Phase 1 | 18 | Daratumumab + DA-EPOCH | qzrxhgoquf(weembchxxb) = a total of 48 SAEs occurred. Grade 4 heme toxicity is the expectation of DA-EPOCH which targets an ANC <500 at least once in each treatment cycle. Grade 4 neutropenia was noted in 10 pts, grade 4 thrombocytopenia in 5, grade 4 lymphopenia in 3. The remainder of the SAEs were typical of EPOCH. ebrhmjophz (cuhgskhlsq ) | Positive | 06 Dec 2025 | ||
Phase 2 | 30 | fbopxpgghv(jvvevywmse) = Grade 3 or greater events included neutropenia (50%), lymphocytopenia (40%), leukopenia (23%), thrombocytopenia (10%), and anemia (3%) but were manageable with growth factor support and/or iber dose-reduction, as needed. misxlvcvot (knbhjrnqkk ) View more | Positive | 06 Dec 2025 |






